FDA.reportPublic FDA data

N/A

Primary DI
00841036032968
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
20-0004
Catalog number
20-0004
Published
2018-08-28
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
EFLFORCEPS, DRESSING, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFLForceps, Dressing, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036032968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036032968008410360329688410360329680841036032968

GMDN Terms#

Term, Definition table
TermDefinition
Dental dressing forceps, reusableA hand-held manual dental instrument designed for grasping and holding a dental dressing during its application to a patient's oral cavity. It typically has a tweezers-like design with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel and is available in various sizes. 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
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
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00888233016902N/ASP-2482SP-24822020-06-16
008882330182272.0MM SYSTEMSP-2640SP-26402020-06-16
00888233078986VENAPAX XLVPX40002025-03-31
00888233012430N/ASP-1634SP-16342020-06-16
00888233013680CMF SYSTEMSP-1883SP-18832020-06-16
00888233013703CMF SYSTEMSP-1884SP-18842020-06-16
00888233013727CMF SYSTEMSP-1885SP-18852020-06-16
00888233013741CMF SYSTEMSP-1886SP-18862020-06-16
00888233025348LactoSorb SystemSP-1688SP-16882020-06-16
00888233025355LactoSorb SystemSP-1689SP-16892020-06-16
00888233025362LactoSorb SystemSP-1690SP-16902020-06-16
00888233025379LactoSorb System - MandibularSP-1778SP-17782020-06-16
00888233025386LactoSorb System - MandibularSP-1779SP-17792020-06-16
00888233025645LactoSorb System - MandibularSP-1944SP-19442020-06-16
00810128536875PECTUS BLU (TM)78-850078-85002024-09-30
00888233077170PECTUS BLU (TM)78-800078-80002024-09-30
00888233077187PECTUS BLU (TM)78-808078-80802024-09-30
00888233077194PECTUS BLU (TM)78-808178-80812024-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB7960TBS BASICSACME ENTERPRISE.EFL2026-05-22
G149TBSB7970TBS BASICSACME ENTERPRISE.EFL2026-05-22
G149TBSB7980TBS BASICSACME ENTERPRISE.EFL2026-05-22
B382S2511200Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382S2548010Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382S2548020Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382S2871200Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382SD9025111020Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382SD9027671000Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382SD9029931200Surgical DirectSurgical Direct, Inc.EFL2026-03-09
G1493807407TBS DentalACME ENTERPRISE.EFL2026-03-02
G1493807508TBS DentalACME ENTERPRISE.EFL2026-03-02
B382S349601020Surgical DirectSurgical Direct, Inc.EFL2026-02-10
B382SD902544180Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD9025471040Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD90260200Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD9028531460Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD9028532000Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD9028532510Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD9028541010Surgical DirectSurgical Direct, Inc.EFL2026-02-04
00841013120718Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120725Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120732Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120749Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120756Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120763Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120770Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120787Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120794Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120800Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06