FDA.reportPublic FDA data

NA

Primary DI
03700386981272
Brand
NA
Company
TORNIER
Model
MWA682
Catalog number
MWA682
Device description
KOLBEL RETRACTOR
Published
2022-08-08
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
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700386981272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700386981272037003869812723700386981272

GMDN Terms#

Term, Definition table
TermDefinition
Human-derived demineralized bone matrix implantAn implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The device is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for the stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is available in the form of powder, crushed granules, putty, chips, or a gel that can be injected through a syringe.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+330476613500order@tornier.com

Regulatory Flags#

DUNS number
260324876
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700434023831BlueprintBPUE0014.2.Mac2025-06-17
03700434023848BlueprintBPUE0014.2.Win2025-06-17
03700386968303Aequalis FractureMWA302MWA3022022-08-08
03700386915260AEQUALISDWB1512015-10-16
03700386916144AEQUALIS REVERSEDDWB9352015-10-16
03700386916151AEQUALIS REVERSEDDWB9362015-10-16
03700386916618AEQUALIS REVERSEDDWD0022015-10-16
03700386916731AEQUALIS REVERSEDDWD0692015-10-16
03700386931529AEQUALIS REVERSED ADAPTERDWD8632015-10-16
03700386931536AEQUALIS REVERSED ADAPTERDWD8642015-10-16
03700386931543AEQUALIS REVERSED ADAPTERDWD8652015-10-16
03700386925726BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATIONMWJ0212017-04-03
03700386955648BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATIONMWJ0032016-09-11
03700386955655BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATIONMWJ0042017-04-03
03700386915062AEQUALIS GLENOIDDWB0012016-01-28
03700386915079AEQUALIS GLENOIDDWB0022015-10-16
03700386915086AEQUALIS GLENOIDDWB0032015-10-16
03700386915093AEQUALIS GLENOIDDWB0052015-10-16
03700386915109AEQUALIS GLENOIDDWB0062015-10-16
03700386915413AEQUALIS GLENOIDDWB2102015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433826MillenniumAvalign Technologies, Inc.GAD2026-10-08
00190776433833MillenniumAvalign Technologies, Inc.GAD2026-10-08
00190776433871MillenniumAvalign Technologies, Inc.GAD2026-10-08
00190776434014MillenniumAvalign Technologies, Inc.GAD2026-10-08
00190776436285MillenniumAvalign Technologies, Inc.GAD2026-10-08
00190776433628MillenniumAvalign Technologies, Inc.GAD2026-10-07
00190776433642MillenniumAvalign Technologies, Inc.GAD2026-10-07
00190776433659MillenniumAvalign Technologies, Inc.GAD2026-10-07
00190776433741MillenniumAvalign Technologies, Inc.GAD2026-10-07
00190776434526MillenniumAvalign Technologies, Inc.GAD2026-10-07
00190776436179MillenniumAvalign Technologies, Inc.GAD2026-10-07
G141518123170Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-10-07
G141518861000Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-10-07
G141572107210Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-10-07
G14157211050Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-10-07
G141572114910Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-10-07
00190776433543MillenniumAvalign Technologies, Inc.GAD2026-10-06
00841536148497ThompsonThompson Surgical Instruments, Inc.GAD2026-10-06
B7687419600Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.GAD2026-10-06
00190776433086MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433116MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433154MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776433161MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776432959MillenniumAvalign Technologies, Inc.GAD2026-09-30
00190776432997MillenniumAvalign Technologies, Inc.GAD2026-09-30
G1415180500Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141518555120Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141528202010Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572105820Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572106810Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30