Integra

Primary DI
B504OM33340
Brand
Integra
Company
Provision
Model
33-34
Published
2022-08-15
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
LRYPunch, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B504OM33340PrimaryHIBCC0

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 may also knot, cut and/or tighten the sutures/ligature loop during or after placement. 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. 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
10304040193270Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193287Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193294Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193300Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193317Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193324Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193331Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193348Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10304040193355Henry ScheinHENRY SCHEIN, INC.LRY2025-11-26
10198459343520MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KDC2025-05-22
10192253052404DevonCardinal Health 200, LLCKDC2025-03-27
10304040177829Henry ScheinHENRY SCHEIN, INC.LRY2025-03-05
10304040177836Henry ScheinHENRY SCHEIN, INC.LRY2025-03-05
10304040177850Henry ScheinHENRY SCHEIN, INC.LRY2025-03-05
10304040177867Henry ScheinHENRY SCHEIN, INC.LRY2025-03-05
10304040177874Henry ScheinHENRY SCHEIN, INC.LRY2025-03-05
10304040177881Henry ScheinHENRY SCHEIN, INC.LRY2025-03-05
10304040177904Henry ScheinHENRY SCHEIN, INC.LRY2025-03-05
10304040177843Henry ScheinHENRY SCHEIN, INC.LRY2025-02-17
10304040177898Henry ScheinHENRY SCHEIN, INC.LRY2025-02-17
10080196415472MedlineMEDLINE INDUSTRIES, INC.KDC2023-06-22
10195327122409Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDC2022-08-04
10192253045284ArgyleCardinal Health 200, LLCKDC2022-08-02
10653160308461CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2022-01-02
10653160316978CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2022-01-02
10653160317012CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2022-01-02
10653160328629CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2022-01-02
10653160236818CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2022-01-01
10653160250326CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2022-01-01
10653160258421CenturionCENTURION MEDICAL PRODUCTS CORPORATIONKDC2022-01-01