FDA.reportPublic FDA data

MODULAR HEAD CLAMP

Primary DI
05019279923465
Brand
MODULAR HEAD CLAMP
Company
Biomet Uk Ltd
Model
31-555530
Catalog number
31-555530
Published
2017-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05019279923465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05019279923465050192799234655019279923465

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft), trial implant, or sizer (e.g., glenoid defect sizer) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during an orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
219322575
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05019279477333Oxford Partial Knee SystemFemoral Impactor32-42012732-4201272020-05-23
05019279905638OXFORD UNICOMPARTMENTAL KNEE PHASE 3TIBIAL IMPACTOR32-42093232-4209322020-05-23
05019279439935Oxford® Partial Knee System32-42297432-4229742020-05-23
05019279439942Oxford® Partial Knee System32-42297532-4229752020-05-23
05019279439959Oxford® Partial Knee System32-42297632-4229762020-05-23
00880304525672Oxford® Partial Knee System32-42209732-4220972025-01-10
00887868259050Oxford® Partial Knee System1100317791100317792025-01-10
00887868354694Oxford® Partial Knee System1665701665702025-01-10
00887868354700Oxford® Partial Knee System1665711665712025-01-10
00887868354717Oxford® Partial Knee System1665721665722025-01-10
00887868354724Oxford® Partial Knee System1665731665732025-01-10
00887868354731Oxford® Partial Knee System1665741665742025-01-10
00887868354748Oxford® Partial Knee System1665751665752025-01-10
00887868354755Oxford® Partial Knee System1665761665762025-01-10
00887868354762Oxford® Partial Knee System1665771665772025-01-10
00887868354779Oxford® Partial Knee System1665781665782025-01-10
00887868354786Oxford® Partial Knee System1665791665792025-01-10
00887868354793Oxford® Partial Knee System1665801665802025-01-10
00887868354809Oxford® Partial Knee System1665811665812025-01-10
00887868354816Oxford® Partial Knee System1668451668452025-01-10

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Primary DI, Brand, Company table
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00190776415235MillenniumAvalign Technologies, Inc.GDJ2026-01-27
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00850037180004USB G2 Detachable Vascular Clamp System - 60mm Straight ArmUSB Medical LimitedGDJ2026-01-07
00850037179886USB G2 Detachable Vascular Clamp System - 40mm Curved Arm SetUSB Medical LimitedGDJ2026-01-06
00850037179893USB G2 Detachable Vascular Clamp System - 40mm Straight ArmUSB Medical LimitedGDJ2026-01-06
00850037179909USB G2 Detachable Vascular Clamp System - Right Angle ArmUSB Medical LimitedGDJ2026-01-06
00850037179916USB G2 Detachable Vascular Clamp System - 60mm Curved ArmUSB Medical LimitedGDJ2026-01-06
00850037179923USB G2 Detachable Vascular Clamp System - 60mm Straight ArmUSB Medical LimitedGDJ2026-01-06
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00850037179947USB G2 Detachable Vascular Clamp System - 94mm Gentle Curved ArmUSB Medical LimitedGDJ2026-01-06
00850037179954USB G2 Detachable Vascular Clamp System - 95mm Straight ArmUSB Medical LimitedGDJ2026-01-06
00850037179961USB G2 Detachable Vascular Clamp SystemUSB Medical LimitedGDJ2026-01-06
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00850037179992USB G2 Detachable Vascular Clamp System - 93mm Curved ArmUSB Medical LimitedGDJ2026-01-06
03662663126373Vital MIS Spinal Fixation SystemHighridge Medical, LLCGDJ2025-12-03
00190776411169MillenniumAvalign Technologies, Inc.GDJ2025-09-22
00190776411176MillenniumAvalign Technologies, Inc.GDJ2025-09-22
00190776411206MillenniumAvalign Technologies, Inc.GDJ2025-09-22
00190776411251MillenniumAvalign Technologies, Inc.GDJ2025-09-22
00190776409937MillenniumAvalign Technologies, Inc.GDJ2025-09-08
04059453070975Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2025-09-01
04059453073891Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2025-09-01
04059453175069Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2025-08-28
04059453136732Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2025-08-25
04059453175083Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2025-08-25