FDA.reportPublic FDA data

Epidural Anesthesia Kit Clint Pharmaceuticals

Primary DI
00628725050379
Brand
Epidural Anesthesia Kit Clint Pharmaceuticals
Company
CHS USA Inc.
Model
CPT6
Catalog number
CPT6
Device description
SINGLE SHOT EPIDURAL TRAY
Published
2026-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OGEEpidural Anesthesia Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGEEpidural Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50628725050374PackageGS130In Commercial Distribution
00628725050379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5062872505037450628725050374
00628725050379006287250503796287250503790628725050379

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
118995594
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628725050416Epidural Anesthesia Kit Clint PharmaceuticalsCPT7CPT72026-07-21
00628725050287Nerve Block Tray Clint PharmaceuticalsCPT22Q45CPT22Q452026-07-20
00628725050294Nerve Block Tray Clint PharmaceuticalsCPT25Q35CPT25Q352026-07-20
00628725050300Epidural Anesthesia Kit Clint PharmaceuticalsCPT3CPT32026-07-20
00628725050331Epidural Anesthesia Kit Clint PharmaceuticalsCPT5CPT52026-07-20
00628725050362Epidural Anesthesia Kit Clint PharmaceuticalsCPT5SPCPT5SP2026-07-20
00628725050409Epidural Anesthesia Kit Clint PharmaceuticalsCPT6SPCPT6SP2026-07-20
00628725050423Epidural Anesthesia Kit Clint PharmaceuticalsCPT7SPCPT7SP2026-07-20
00628725050188Nerve Block TrayCPT110CPT1102026-07-17
00628725050195Nerve Block TrayCPT11CHCPT11CH2026-07-17
00628725050201Nerve Block TrayCPT11KCCPT11KC2026-07-17
00628725050232Epidural Anesthesia Kit Clint PharmaceuticalsCPT17SPGCPT17SPG2026-07-17
00628725050249Epidural Anesthesia Kit Clint PharmaceuticalsCPT18LCPT18L2026-07-17
00628725050256Epidural Anesthesia Kit Clint PharmaceuticalsCPT20LCPT20L2026-07-17
00628725050270Epidural Anesthesia Kit Clint PharmaceuticalsCPT20SCPT20S2026-07-17
00628725050324Epidural Anesthesia KitCPT4SPCPT4SP2026-07-17
00628725050003Nerve Block TrayCPT11CPT112025-11-20
00628725050058Epidural Anesthesia KitCPT4CPT42025-11-24
00628725050010Nerve Block TrayCPT11SPCPT11SP2025-11-20
00628725050041Epidural Anesthesia KitCPT10ATCPT10AT2025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628725050416Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-21
00628725050300Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-20
00628725050331Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-20
00628725050362Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-20
00628725050409Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-20
00628725050423Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-20
10198956522015CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-20
B098AMS11096B0Aligned Medical SolutionsAligned Medical SolutionsOGE2026-07-19
B098AMS188250Aligned Medical SolutionsAligned Medical SolutionsOGE2026-07-19
00628725050232Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-17
00628725050249Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-17
00628725050256Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-17
00628725050270Epidural Anesthesia Kit Clint PharmaceuticalsCHS USA Inc.OGE2026-07-17
00628725050324Epidural Anesthesia KitCHS USA Inc.OGE2026-07-17
B098AMS12381C0Aligned Medical SolutionsAligned Medical SolutionsOGE2026-07-12
10198956460003CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-09
10198956458529CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-06
10198956518698CARDINAL HEALTHCardinal Health 200, LLCOGE2026-07-06
B098AMS10930A0Aligned Medical SolutionsAligned Medical SolutionsOGE2026-07-03
10198956466104CARDINAL HEALTHCardinal Health 200, LLCOGE2026-06-08
10198956483255CARDINAL HEALTHCardinal Health 200, LLCOGE2026-06-03
04046955862634Design Options®B. BRAUN MEDICAL INC.OGE2026-06-01
04046955966264Design Options®B. BRAUN MEDICAL INC.OGE2026-06-01
10198956316096CARDINAL HEALTHCardinal Health 200, LLCOGE2026-06-01
00628725050041Epidural Anesthesia KitCHS USA Inc.OGE2025-11-24
00628725050058Epidural Anesthesia KitCHS USA Inc.OGE2025-11-24
00628725050065Epidural Anesthesia KitCHS USA Inc.OGE2025-11-24
10193489431926Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGE2023-06-08
10195594691356CARDINAL HEALTHCardinal Health 200, LLCOGE2023-04-04
10195594804459CARDINAL HEALTHCardinal Health 200, LLCOGE2023-01-25