FDA.reportPublic FDA data

ZIMMER® TRABECULAR METALTM REVERSE SHOULDER SYSTEM INSTRUMENTATION

Primary DI
00847538004137
Brand
ZIMMER® TRABECULAR METALTM REVERSE SHOULDER SYSTEM INSTRUMENTATION
Company
SYMMETRY MEDICAL INC.
Model
00-4361-073-25
Catalog number
11-167-025
Device description
ZIMMER® TRABECULAR METALTM REVERSE SHOULDER SYSTEM INSTRUMENTATION TECOMET 7.5MM X 25 MM DRILL
Published
2019-06-18
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

Related Records

Contact Domains

Product Codes

CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications

CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847538004137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847538004137008475380041378475380041370847538004137

GMDN Terms

TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
574-267-8700sales@tecomet.com

Regulatory Flags

DUNS number
079881212
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
false
Sterilization required before use
true

Other Devices From This Company

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00847538008654HP Extraction Standard Removal Case87-10082011-03-0482023-11-28
00847538009330Long Radial Osteotome Blade11-127-5032500-10-7552023-10-23
00847538009293Short Radial Osteotome Blade11-127-5012500-10-7532023-09-22
00847538009316Medium Radial Osteotome Blade11-127-5022500-10-7542023-09-22
00847538009354Long Flat Osteotome Blade11-130-5012500-10-7522023-09-22
00847538009378Medium Flat Osteotome Blade11-130-5022500-10-7512023-09-22
00847538018721GLOBAL UNITE™ Short Stem Instrumentation2128118002021-09-01
00847538018738GLOBAL UNITE™ Short Stem Instrumentation2128111002021-09-01
00847538018745GLOBAL UNITE™ Short Stem Instrumentation2128111202021-09-01
00847538018769GLOBAL UNITE™ Short Stem Instrumentation2128111402021-09-01
00847538018776GLOBAL UNITE™ Short Stem Instrumentation2128111602021-09-01
00847538015256Flexible Osteotome System with Radel Case30-005-0002709-04-000; 30-005-000-15002023-07-17
00847538019179Femoral Tray30-037-4002709-01-000; 30-037-400-15002023-07-17
00817766026423GLOBAL UNITE™ Short Stem Instrumentation2236002112021-09-01
00847538004236Adapter Shaft AO Small To Hudson09-159-0002810010302022-07-22
00847538001006Flag Splitter10-001-00000-9986-010-12;4300012022-05-12
00847538018868Cutting Pliers74-388-0002312201142022-07-12
00847538018882Large Fragment Bone Clamp74-294-0008162990112022-07-12

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