FDA.reportPublic FDA data

N/A

Primary DI
00841036032821
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
19-0015
Catalog number
19-0015
Published
2018-08-28
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
EFLFORCEPS, DRESSING, DENTAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036032821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036032821008410360328218410360328210841036032821

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841036019112N/A02-008302-00832017-06-05
00888233028875Pectus Blu (TM)78-880178-88012026-07-23
00888233028882Pectus Blu (TM)78-880278-88022026-07-23
00888233028899Pectus Blu (TM)78-880378-88032026-07-23
00888233086110Pectus Blu (TM)78-005378-00532026-07-23
00888233086127Pectus Blu (TM)78-005578-00552026-07-23
00888233086134Pectus Blu (TM)78-720078-72002026-07-23
00888233086141Pectus Blu (TM)78-725078-72502026-07-23
00888233086158Pectus Blu (TM)78-730078-73002026-07-23
00888233086165Pectus Blu (TM)78-735078-73502026-07-23
00888233086172Pectus Blu (TM)78-740078-74002026-07-23
00888233086189Pectus Blu (TM)78-745078-74502026-07-23
00888233086196Pectus Blu (TM)78-750078-75002026-07-23
00888233086202Pectus Blu (TM)78-755078-75502026-07-23
00888233086219Pectus Blu (TM)78-800178-80012026-07-23
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00810128536875PECTUS BLU (TM)78-850078-85002024-09-30
00888233077170PECTUS BLU (TM)78-800078-80002024-09-30
00888233077187PECTUS BLU (TM)78-808078-80802024-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9025181000Surgical DirectSurgical Direct, Inc.EFL2026-08-07
B382S2752108T0Surgical DirectSurgical Direct, Inc.EFL2026-08-03
B382S25681060Surgical DirectSurgical Direct, Inc.EFL2026-07-29
B382SD37103120Surgical DirectSurgical Direct, Inc.EFL2026-07-28
B382SD914817010Surgical DirectSurgical Direct, Inc.EFL2026-07-28
00190776400279MillenniumAvalign Technologies, Inc.EFL2026-07-17
00850083275525Intrace USAPILOTIS TECH LLCEFL2026-07-03
05060212051264College Dental Forceps 160mmDTR MEDICAL LIMITEDEFL2026-06-10
B382S28531030Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382S28531040Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382S2853252T0Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382S285401100Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902172106T0Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9023191000Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9027351020Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028531080Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028531260Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028531290Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028531720Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028541100Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028541170Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902861100T0Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902869400Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902870110Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902991101T0Surgical DirectSurgical Direct, Inc.EFL2026-06-08
G149TBSB7960TBS BASICSACME ENTERPRISE.EFL2026-05-22
G149TBSB7970TBS BASICSACME ENTERPRISE.EFL2026-05-22
G149TBSB7980TBS BASICSACME ENTERPRISE.EFL2026-05-22
G149NP380750NPSACME ENTERPRISE.EFL2026-05-01
G149NPRMF0NPSACME ENTERPRISE.EFL2026-05-01