FDA.reportPublic FDA data

N/A

Primary DI
00841036073367
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
CP-1087
Published
2024-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KBLDepressor, Metal Tongue, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBLDepressor, Metal Tongue, SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036073367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036073367008410360733678410360733670841036073367

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

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
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
00888233077194PECTUS BLU (TM)78-808178-80812024-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776397111MillenniumAvalign Technologies, Inc.KBL2026-07-16
09348811004840INKAThe Trustee for KAISER FAMILY TRUSTKBL2025-11-25
09348811004970INKAThe Trustee for KAISER FAMILY TRUSTKBL2025-11-25
00190776407704MillenniumAvalign Technologies, Inc.KBL2025-08-01
00190776407711MillenniumAvalign Technologies, Inc.KBL2025-08-01
00194613046064MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049324MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049348MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049355MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049386MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-08-01
00194613049331MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-03-21
00194613107178MSI Precision Specialty InstrumentsMed Saver, Inc.KBL2025-03-21
00841036058838N/ABIOMET MICROFIXATION, INCKBL2024-09-25
00841036073350N/ABIOMET MICROFIXATION, INCKBL2024-09-25
00887482049150Symmetry AndrewASPEN SURGICAL PRODUCTS, INC.KBL2024-08-15
00840183517243BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183521714BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183522858BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183522865BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183525422BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
00840183525736BR Surgical, LLCBR Surgical, LLCKBL2024-06-10
10381780538547MicroFrance®INTEGRA MICROFRANCEKBL2024-05-29
G586E831252ES0Novo SurgicalNOVO SURGICAL, INC.KBL2023-12-18
G586E98312510Novo SurgicalNOVO SURGICAL, INC.KBL2023-12-18
G586E98312520Novo SurgicalNOVO SURGICAL, INC.KBL2023-12-18
G586E98313210Novo SurgicalNOVO SURGICAL, INC.KBL2023-12-18
00842331191930Novo Surgical Inc. NOVO SURGICAL, INC.KBL2023-12-07
00190776049034AvalignAvalign Technologies, Inc.KBL2023-09-28
00190776049041AvalignAvalign Technologies, Inc.KBL2023-09-28
00190776290283MILLENNIUMAvalign Technologies, Inc.KBL2023-09-28