FDA.reportPublic FDA data

Conmed/Linvatec

Primary DI
00810041060891
Brand
Conmed/Linvatec
Company
Provision
Model
9906
Published
2019-12-16
Public version status
Update
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
KDCInstrument, Surgical, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810041060891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810041060891008100410608918100410608910810041060891

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, reprocessedA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft; it may in addition knot and/or cut the sutures as they are placed. 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
541-508-7520customersupport@provisiondrs.com

Regulatory Flags#

DUNS number
016889401
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B504OM4515700130DePuy Mitek4515700132026-03-19
B504OM50715940Conmed Linvatec5071-5942026-03-19
B504OMDC119090180Conmed LinvatecDC119-090-182026-03-19
B504OM50711330ConMed Linvatec5071-1332026-02-24
B504OM50721010ConMed Linvatec5072-1012026-02-24
B504OMBR58201070250BrasselerBR5820-107-0252026-02-24
B504OMPDS2NL300NakanishiPDS-2NL-302026-02-09
B504OM13090119XG10Zimmer13090119XG12025-11-25
B504OM19100119XG10Zimmer19100119XG12025-11-25
B504OM20090119XC10Zimmer20090119XC12025-11-25
B504OM20100119XC10Zimmer20100119XC12025-11-25
B504OM20100119XCW0Zimmer20100119XCW2025-11-25
B504OM21090119XGW0Zimmer21090119XGW2025-11-25
B504AE2273010DePuy Mitek 2273012018-04-05
B504AE2273020DePuy Mitek 2273022018-04-05
B504AE2273050DePuy Mitek 2273052018-04-05
B504CBEICA5874010Smith & NephewEICA5874-012018-04-03
B504CBEICA8875010Smith & NephewEICA8875-012018-04-03
B504CBEICA8898010Smith & NephewEICA8898-012018-04-03
B504EICA9820010Smith & NephewEICA9820-012019-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756402545DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402552DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402569DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402576DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402583DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402590DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402606DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402613DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402620DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402637DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402644DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402651DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402675DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402682DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402712DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402729DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402736DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402743DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402774DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402538DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-06-26
05060212051721Clamp Cover Red (Small) 50mmDTR MEDICAL LIMITEDKDC2026-06-10
05060212051738Clamp Cover White (Med) 120mmDTR MEDICAL LIMITEDKDC2026-06-10
05060212051745Clamp Cover Blue (Large) 120mmDTR MEDICAL LIMITEDKDC2026-06-10
10198459343520MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDC2025-05-22
10192253052404DevonCardinal Health 200, LLCKDC2025-03-27
10653160385769MEDLINEMEDLINE INDUSTRIES, INC.KDC2025-01-29
10653160383208CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2024-12-03
10653160383123MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160383130MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21
10653160383147MEDLINEMEDLINE INDUSTRIES, INC.KDC2024-11-21