FDA.reportPublic FDA data

PERFUSE HANDLE ASSEMBLY

Primary DI
00880304999633
Brand
PERFUSE HANDLE ASSEMBLY
Company
Biomet Biologics, LLC
Model
800-0545
Catalog number
800-0545
Published
2016-11-03
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
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141762000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141762000PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEMBiomet, Inc.2014-08-27FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304999633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304999633008803049996338803049996330880304999633

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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
802003074
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350023774307Calcibon401163000140116300012025-10-09
00880304640962Bilateral BMA Kit800-0710800-07102021-10-30
00887868284830Calcigen® S Bone Graft System3480103480102019-01-11
00887868284847Calcigen® S Bone Graft System3480123480122019-01-11
00887868284854Calcigen® S Bone Graft System3480143480142019-01-11
00880304400092Plasmax® Counterbalance800-0510800-05102019-06-11
00880304443112Plasmax® Plus Counterbalance800-0512800-05122019-06-11
00880304484757Biomet®800-0270800-02702019-06-11
00887868306730Biomet® Biologics800-0274800-02742019-06-11
00887868263033Perfuse™ Decompression System800-0542800-05422019-04-18
00880304451759BMA Kit800-0705800-07052019-02-22
00880304460645GPS® III800-0744800-07442016-11-03
00880304460652GPS® III800-0745800-07452016-11-03
00880304508781BIOMET® BIOLOGICS800-0274800-02742016-11-03
00880304521513GPS®III Mini Platelet Concentration System800-0505A800-0505A2018-11-13
00880304640856Plasmax® Plasma Concentration Kit800-0516800-05162018-11-27
00880304640917BioCUE®800-0614800-06142016-11-03
00880304640924BioCUE®800-0615800-06152016-11-03
00880304641068GPS® III PLATELET CONCENTRATION SYSTEM800-1006A800-1006A2016-11-03
00880304680333PERFUSE DECOMPRESSION INSTRUMENTATION800-0546800-05462016-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982458119INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14
00193982458126INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14
00193982504403INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14
00884450487402Merit Medical®Merit Medical Systems, Inc.FMF2026-08-07
08800045103061Feel Ject(FIS-054, U-100, 1.0cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105164Feel Ject(FIS-202, U-100, 0.3 cc, 29G x 12.7mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105256Feel Ject(FIS-205, U-100, 0.3 cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105492Feel Ject(FIS-213, U-100, 1.0cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105614Feel Ject(FIS-217, U-100, 0.5 cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
00810131885045ION Non CervicalSurgentec, LLCFMF2026-07-28
00884450486955Merit Medical®Merit Medical Systems, Inc.FMF2026-07-25
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03