FDA.reportPublic FDA data

N/A

Primary DI
00841036024215
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
03-1150
Catalog number
03-1150
Published
2018-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXGTAMP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXGTampOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036024215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036024215008410360242158410360242150841036024215

GMDN Terms#

Term, Definition table
TermDefinition
Surgical tamp, reusableA hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags#

DUNS number
046189866
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841036007621N/A01-037001-03702017-04-06
00841036007638N/A01-037101-03712017-04-06
00841036008819N/A01-145501-14552017-04-11
00841036159139N/A01-037601-03762017-04-06
00841036240448WALTERLORENZ™ SURGICAL ASSIST ARMWAL305WAL3052019-06-17
00888233078986VENAPAX XLVPX40002025-03-31
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00841036054229N/A915-2055915-20552015-10-11
00841036077969N/A915-2057915-20572015-10-15
00888233005371PECTUS SYSTEM01-390701-39072020-06-17
00888233011334RIBFIX BLU SYSTEM76-000376-00032020-06-18
00888233011587RIBFIX BLU SYSTEM76-119576-11952020-06-18
008882330161311.5MM SYSTEMSP-2335SP-23352020-06-16
008882330161862.0MM SYSTEMSP-2347SP-23472020-06-16
00888233018272TRAUMAONE SYSTEMSP-3228SP-32282020-06-17
00888233022385N/ASP-3139SP-31392020-06-17
00888233018296N/ASP-32302024-09-26
00888233069342STERNALOCK EZ115.101.04115.101.042024-05-29
00888233069359STERNALOCK EZ115.102.06115.102.062024-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08031497003689Mendec® Kypho Set Monolateral 10 mmTECRES SPAHXG2025-12-17
08031497003696Mendec® Kypho Set Monolateral 15 mmTECRES SPAHXG2025-12-17
08031497003702Mendec® Kypho Set Monolateral 20 mmTECRES SPAHXG2025-12-17
08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAHXG2025-12-17
08031497003818Mendec® Kypho Set Bilateral 15 mmTECRES SPAHXG2025-12-17
08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAHXG2025-12-17
08800038029323SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029330SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029347SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029354SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029361SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029378SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029415SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038029422SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039407SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039414SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039421SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039438SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039445SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039452SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039469SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038039476SteriSpine VA IMEDICOM CO., LTD.HXG2025-09-24
08800038058262SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
08800038058279SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
08800038058286SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
08800038058293SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
08800038058309SYNTH™ PLUSIMEDICOM CO., LTD.HXG2024-03-25
08800038058316SYNTH™ PLUS BILATERALIMEDICOM CO., LTD.HXG2024-03-25
08800038058323SYNTH™ PLUS BILATERALIMEDICOM CO., LTD.HXG2024-03-25
08800038058330SYNTH™ PLUS BILATERALIMEDICOM CO., LTD.HXG2024-03-25