FDA.reportPublic FDA data

N/A

Primary DI
00841036021535
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
02-5227
Catalog number
02-5227
Published
2017-06-16
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
FMADEPRESSOR, TONGUE, NON-SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMADepressor, Tongue, Non-SurgicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036021535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036021535008410360215358410360215350841036021535

GMDN Terms#

Term, Definition table
TermDefinition
Tongue depressor, surgicalA hand-held surgical instrument designed to displace and maintain the tongue in a fixed position, usually by depressing it towards the floor of the mouth. It is typically a metallic (e.g., high-grade stainless steel) device either with a straight shape, or more frequently smoothly bent at its center (e.g., to a 90? arch). The proximal end is used as a handle, while the distal end (usually serrated and may include holes) is used to depress the tongue. The device is used in oral surgery (e.g., during tonsillectomy). 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
05010058183605InstrapacROBINSON HEALTHCARE LIMITEDFMA2025-09-11
M220720005Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
M220769003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
M220770003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
00887482032756Symmetry Surgical®SYMMETRY SURGICAL INC.FMA2024-08-15
00887482032763Symmetry Surgical®SYMMETRY SURGICAL INC.FMA2024-08-15
00887482049167Symmetry Surgical®SYMMETRY SURGICAL INC.FMA2024-08-15
00887482049174Symmetry Surgical®SYMMETRY SURGICAL INC.FMA2024-08-15
20884392954455Safety 1stDOREL JUVENILE GROUP, INC.FMA2023-10-15
16973069980020Tongue DepressorDalian Rongbang Medical Healthy Devices Co., Ltd.FMA2023-10-04
00732094082326Welch Allyn, Inc.WELCH ALLYN, INC.FMA2023-08-17
10810132041157HCSConcordance Healthcare Solutions LLCFMA2023-05-12
10810132041164HCSConcordance Healthcare Solutions LLCFMA2023-05-12
10810132041171HCSConcordance Healthcare Solutions LLCFMA2023-05-12
10810132041188HCSConcordance Healthcare Solutions LLCFMA2023-05-12
30613647021270FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FMA2022-12-07
30613647021287FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FMA2022-12-07
20613647021396FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.FMA2022-12-07
10843471131302DefendYoung Innovations, Inc.FMA2022-10-30
06973069980016DepressorsDalian Rongbang Medical Devices Co.,Ltd.FMA2022-09-07
26973069980010DepressorsDalian Rongbang Medical Devices Co.,Ltd.FMA2022-09-07
50732224003219Tongue DepressorsCROSSTEX INTERNATIONAL, INC.FMA2022-08-19
00192029049396Tongue-Away SheildTP ORTHODONTICS INCFMA2022-05-09
00192029049402Tongue-Away SheildTP ORTHODONTICS INCFMA2022-05-09
00192029049419Tongue-Away SheildTP ORTHODONTICS INCFMA2022-05-09
00192029049426Tongue-Away SheildTP ORTHODONTICS INCFMA2022-05-09
00192029049433Tongue-Away SheildTP ORTHODONTICS INCFMA2022-05-09
00192029049440Tongue-Away SheildTP ORTHODONTICS INCFMA2022-05-09
00192029049457Tongue-Away SheildTP ORTHODONTICS INCFMA2022-05-09
00192029049471Tongue-Away SheildTP ORTHODONTICS INCFMA2022-05-09