FDA.reportPublic FDA data

Universal Block Procedure Trays

Primary DI
00850014433642
Brand
Universal Block Procedure Trays
Company
DISTRIBUTION UNLIMITED, LLC
Model
1
Catalog number
DU3640
Device description
include a wide selection of support materials and quality components needed to perform many pain management procedures.
Published
2020-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
FPASet, Administration, Intravascular
NABGauze / Sponge,Nonresorbable For External Use
OFQAnesthesia Kit
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FPASet, Administration, IntravascularGeneral Hospital2
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1
OFQAnesthesia KitAnesthesiology2
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850014433646PackageGS120In Commercial Distribution
00850014433642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085001443364620850014433646
00850014433642008500144336428500144336420850014433642

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge18Gauge
Needle Gauge25Gauge
Shaft Length1.5Inch
Total Volume3Milliliter
Total Volume5Milliliter
Total Volume10Milliliter

Regulatory Flags#

DUNS number
926603486
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014433253Syringe 3ml w/o Needle1DU25032020-08-06
00850014433260Syringe 5ml w/o Needle1DU25052020-08-06
00850014433284Syringe 10ml w/o Needle1DU25102020-08-06
00850014433161Grounding Pads1DU21002020-08-13
00850014433130"IV Extension Set 6"" "1DU22602020-08-19
00850014433222"Tourniquet 1""x18"""1DU22102020-08-06
00850014433215ETCO2 Nasal Cannula1DU10902020-08-13
00850014433505"Cohesive bandage 2""x5yds stretched"1DU35502020-08-06
10850014433137IV Extension Set 6" 1DU22602020-08-19
20850014433646Universal Block Procedure Trays1DU36402020-08-19
00850014433239Sterile Specimen Cup with Temp Strip1DU31002020-08-13
00850014433154Nasal Oxygen Cannula1DU10102020-08-13
10850014433168Grounding Pads1DU21002020-08-13
20850014433219ETCO2 Nasal Cannula1DU10902020-08-13
10850014433236Sterile Specimen Cup with Temp Strip1DU31002020-08-13
00850014433109Anesthesia Mask (Large) 1DU10782020-08-06
00850014433123Anesthesia Mask (Medium) 1DU10732020-08-06
00850014433178"Ice Compress 4""x7"""1DU17032020-08-06
00850014433246Non Woven Sponge 2x2 4 ply 1DU12022020-08-06
00850014433291"3ml Syringe w/ 18g x 1"" Needle"1DU25232020-08-06

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