FDA.reportPublic FDA data

MEDLINE

Primary DI
10888277386938
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
KM5100373RH
Catalog number
KM5100373RH
Device description
KM5100-37-115 RECP RASP,SM BONE,FOR M
Published
2025-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888277386938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088827738693810888277386938

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, reciprocating, single-useA surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to be attached to a reciprocating power tool handpiece to scrape and smooth the surface of bone during a surgical procedure. It has grooves/teeth along all or part of the distal working end and is made of metal [e.g., stainless steel, titanium (Ti)]; it is not dedicated for use at a specific anatomy (e.g., sinus, ear). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888277419452MEDLINEMDTZ1068516ABMDTZ1068516AB2016-10-14
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B35675400020American MedicalsAmerican MedicalsGAC2026-05-20
05055445940881SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940898SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940904SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940911SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940928SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973001SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973018SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973025SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973032SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973049SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
00190776421014MillenniumAvalign Technologies, Inc.GAC2026-04-30
B356ED469970American MedicalsAmerican MedicalsGAC2026-04-07
B356ED470040American MedicalsAmerican MedicalsGAC2026-04-07
B356ED470050American MedicalsAmerican MedicalsGAC2026-04-07
B356FF114000American MedicalsAmerican MedicalsGAC2025-05-27
B356FF115000American MedicalsAmerican MedicalsGAC2025-05-27
B356FF115020American MedicalsAmerican MedicalsGAC2025-05-27
10888277374324MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-02-14
10888277382992MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-02-14
10080196382989MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10080196384983MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277374515MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377004MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377011MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377509MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277381971MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277382442MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277384286MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277384415MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29