FDA.reportPublic FDA data

NA

Primary DI
10888551012966
Brand
NA
Company
STERILMED, INC.
Model
AUT174317
Catalog number
174317
Device description
ENDO CLINCH II STANDARD
Published
2018-06-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDAForceps, obstetrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDAForceps, ObstetricalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888551012966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088855101296610888551012966

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic grasping forceps, single-useA flexible manual device intended to be used in combination with a compatible endoscope to grasp tissue (typically atraumatically) or foreign bodies. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of scissors-like grasping tongs or claws which are operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through the working channel of the endoscope. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(888)541-0078customerservice@sterilmed.com
+1(888)541-0078sterilmedcs@its.jnj.com

Regulatory Flags#

DUNS number
175899459
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888551004312NAMID7BA407BA402018-06-18
10888551004329NAMID7BA40D7BA40D2018-06-18
10888551017862NALIN5052-1865052-1862018-06-18
10888551035224NASTR1608-2-111608-2-112018-06-18
10888551045292NASYN03.312.090SYN03.312.0902019-11-15
10888551045308NASYN03.312.120SYN03.312.1202019-11-15
10888551045315NASYN394.88SYN394.882019-11-15
10888551045322NASYN03.312.680SYN03.312.6802019-11-15
10888551045339NASYN394.89SYN394.892019-11-15
10888551045346NASYN394.90SYN394.902019-11-15
10888551045353NASYN394.91SYN394.912019-11-15
10888551045360NASYN394.92SYN394.922019-11-15
10888551045377NASYN03.312.620SYN03.312.6202019-11-15
10888551045384NASYN03.312.650SYN03.312.6502019-11-15
10888551045391NASYN03.312.710SYN03.312.7102019-11-15
10888551045407NASYN03.312.740SYN03.312.7402019-11-15
10888551045414NASYN03.312.590SYN03.312.5902019-11-15
10888551045421NASYN03.312.350SYN03.312.3502019-11-15
10888551045438NASYN03.312.380SYN03.312.3802019-11-15
10888551045445NASYN03.312.410SYN03.312.4102019-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776419196MillenniumAvalign Technologies, Inc.HDA2026-04-13
00190776416119MillenniumAvalign Technologies, Inc.HDA2026-02-06
00190776409708MillenniumAvalign Technologies, Inc.HDA2025-09-08
00194613119683MSI Precision Specialty InstrumentsMed Saver, Inc.HDA2025-08-01
00190776406271MillenniumAvalign Technologies, Inc.HDA2025-07-21
00850071684261Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDA2025-01-21
00850071684278Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDA2025-01-21
00850071684285Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDA2025-01-21
00850071684292Realstar SurgicalREAL STAR SURGICAL INSTRUMENTSHDA2025-01-21
00190776387969MillenniumAvalign Technologies, Inc.HDA2024-11-12
00190776387075MillenniumAvalign Technologies, Inc.HDA2024-09-06
00190776384883MillenniumAvalign Technologies, Inc.HDA2024-08-26
00887482030196Symmetry AuvardASPEN SURGICAL PRODUCTS, INC.HDA2024-08-07
00887482043585Symmetry DeLeeASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00887482043615Symmetry Kielland-LuikartASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00887482078877Symmetry ElliotASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00887482078914Symmetry KiellandASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00887482078976Symmetry BartonASPEN SURGICAL PRODUCTS, INC.HDA2024-08-06
00840183505509BR Surgical, LLCBR Surgical, LLCHDA2024-07-22
00840183513344BR Surgical, LLCBR Surgical, LLCHDA2024-07-22
00190776127640MillenniumAvalign Technologies, Inc.HDA2023-11-14
00190776142698MillenniumAvalign Technologies, Inc.HDA2023-11-14
00190776143886MillenniumAvalign Technologies, Inc.HDA2023-11-14
00190776250744AvalignAvalign Technologies, Inc.HDA2023-11-13
00190776250089AvalignAvalign Technologies, Inc.HDA2023-09-28
00190776296797MILLENNIUMAvalign Technologies, Inc.HDA2023-09-28
00190776371241MILLENNIUMAvalign Technologies, Inc.HDA2023-09-28
00810123206148Adler Instrument CompanyAdler, Inc.HDA2023-08-24
00190776369125MillenniumAvalign Technologies, Inc.HDA2023-04-03
00840319750346Hayden MedicalHayden Medical, Inc.HDA2023-03-21