FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446729235
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
804-09-041
Device description
ALTIVATE ANATOMIC AG, GLENOID RASP SI, SZ 54
Published
2022-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTRRASP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446729235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446729235001904467292351904467292350190446729235

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
154074504
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446839187DJO SURGICAL804-06-4182024-06-27
00190446839194DJO SURGICAL804-06-4192024-06-27
00190446839200DJO SURGICAL804-06-3182024-06-27
00190446839217DJO SURGICAL804-06-3192024-06-27
00888912024884DJO SURGICAL520-00-0002017-08-07
00190446263906DJO SURGICAL354-10-0402018-07-16
00190446264156DJO SURGICAL354-10-0652018-07-16
00190446264163DJO SURGICAL354-12-0402018-07-16
00190446264170DJO SURGICAL354-12-0652018-07-16
00190446264187DJO SURGICAL354-14-0402018-07-16
00190446264194DJO SURGICAL354-14-0652018-07-16
00190446978213DJO SURGICALS-2019692026-05-01
00190446978268DJO SURGICALS-2019702026-05-01
00190446978275DJO SURGICALS-2019712026-05-01
00190446978282DJO SURGICALS-2019722026-05-01
00888912078634DJO SURGICAL425-97-0052017-08-07
00888912078641DJO SURGICAL425-97-0062017-08-07
00888912078658DJO SURGICAL425-97-0072017-08-07
00888912078665DJO SURGICAL425-97-0082017-08-07
00888912078672DJO SURGICAL425-97-0092017-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806395408917PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408924PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408931PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408948PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408955PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408962PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408979PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408986PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395408993PulsarGS Medical Co., Ltd.HTR2022-11-01
08806395409006PulsarGS Medical Co., Ltd.HTR2022-11-01
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10381780507888Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-09-12
10381780393016Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-05-02
10381780280859Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.HTR2018-04-13
10381780280866Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.HTR2018-04-13
10381780467076Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-09
10381780467083Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-09
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10381780189329Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-03
10381780192800Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-03
10381780192817Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780192824Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780192831Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780192848Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780192855Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780192862Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780193012Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-04-02
10381780461616Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-03-22
10381780212188Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-03-01
10381780212195Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTR2018-03-01