FDA.report

Medline

Primary DI
10888277372184
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
16082101RH
Catalog number
16082101RH
Device description
1608-2-101 MICRO BUR,SIDE CTNG,SST 2.
Published
2022-04-08
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

Related Records

Contact Domains

Product Codes

CodeName
GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GFFBur, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10888277372184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088827737218410888277372184

GMDN Terms

TermDefinition
Orthopaedic bur, single-useA sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.

Sterilization Methods

Method

Contacts

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 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 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