FDA.reportPublic FDA data

Medline

Primary DI
20888277403786
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
5071321R
Catalog number
5071321R
Device description
5071-321 CONMED INTREX BLADE SYS FOR TO
Published
2022-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFFBur, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277403786PackageGS15In Commercial Distribution
10888277403789PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827740378620888277403786
1088827740378910888277403789

GMDN Terms#

Term, Definition table
TermDefinition
Surgical saw blade, sagittal, reprocessedA flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at the distal end to cut in a rapid sagittal (side to side) motion; it may in addition cut in an oscillating motion. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24053613296209Bur, tapered, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-20
07613327687637N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687644N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687651N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687668N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687675N/ASTRYKER CORPORATIONGFF2026-03-19
24053613295929Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613295936Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296131Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296193Bur, tapered, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296803Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297121Bur, cylindrical, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297190Bur, Egg / egg shaped, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297206Bur, Egg / egg shaped, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297220Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
10888867516950Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517926Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517933Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517940Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517957Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517964Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544052Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544069Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544076Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544083Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544090Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544106Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544120Arthrex®ARTHREX, INC.GFF2026-03-03
04027497285884GT PODO 0.276 in (7 mm) round Shank 3/32"LUKAS-ERZETT GmbH & Co. KGGFF2026-02-11
04027497285822GT PODO 0.394 in (10 mm) round Shank 3/32"LUKAS-ERZETT GmbH & Co. KGGFF2026-02-10