FDA.reportPublic FDA data

NA

Primary DI
10885862046307
Brand
NA
Company
Exactech, Inc.
Model
201-89-01
Catalog number
201-89-01
Device description
BONE FILE
Published
2022-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HTPFILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTPFileOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862046307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586204630710885862046307

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
157565946
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862653697Alteon190-00-01190-00-012026-05-26
10885862653703Alteon190-00-02190-00-022026-05-26
10885862653710Alteon190-00-03190-00-032026-05-26
10885862653727Alteon190-00-04190-00-042026-05-26
10885862653734Alteon190-00-05190-00-052026-05-26
10885862653741Alteon190-00-06190-00-062026-05-26
10885862653758Alteon190-00-07190-00-072026-05-26
10885862653765Alteon190-00-08190-00-082026-05-26
10885862653772Alteon190-00-09190-00-092026-05-26
10885862653789Alteon190-00-10190-00-102026-05-26
10885862653796Alteon190-00-11190-00-112026-05-26
10885862653802Alteon190-00-12190-00-122026-05-26
10885862653819Alteon190-00-13190-00-132026-05-26
10885862653826Alteon190-00-14190-00-142026-05-26
10885862653833Alteon190-00-15190-00-152026-05-26
10885862653840Alteon190-01-02190-01-022026-05-26
10885862653857Alteon190-01-03190-01-032026-05-26
10885862653864Alteon190-01-04190-01-042026-05-26
10885862653871Alteon190-01-05190-01-052026-05-26
10885862653888Alteon190-01-06190-01-062026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974940306642endophixSuzhou Endophix Co., Ltd.HTP2025-12-12
10818674026618Rasp Down Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2025-08-13
10818674026625Rasp Up Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2025-08-13
00840286841955Consensus Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-22
00840286853965Consensus Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-22
00840286853972Consensus Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-22
00840286841009TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-21
00840286855990TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856003TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856010TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856027TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856034TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840124518742FuzeFix MiniFUSION ORTHOPEDICS, LLCHTP2025-05-13
04046826034801MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHTP2025-05-07
10810128460788Angled Ring Curette, Large RoundT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2024-07-31
10810128460795Angled Ring Curette, Small RoundT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2024-07-31
06974954641050Acetabular file connecting rodXinhua Healthcare Industry Co.,LimitedHTP2024-06-24
06974954641067 Acetabular bone raspXinhua Healthcare Industry Co.,LimitedHTP2024-01-22
06974954641081 Acetabular bone raspXinhua Healthcare Industry Co.,LimitedHTP2024-01-22
06974954641098 Acetabular bone raspXinhua Healthcare Industry Co.,LimitedHTP2024-01-22
06974954641104Acetabular bone raspXinhua Healthcare Industry Co.,LimitedHTP2024-01-22
06974954641111Acetabular bone raspXinhua Healthcare Industry Co.,LimitedHTP2024-01-22
06974954641128 Acetabular bone raspXinhua Healthcare Industry Co.,LimitedHTP2024-01-22
06974954641135 Acetabular bone raspXinhua Healthcare Industry Co.,LimitedHTP2024-01-22
06974954641142 Acetabular bone raspXinhua Healthcare Industry Co.,LimitedHTP2024-01-22
06974954641159 Acetabular bone raspXinhua Healthcare Industry Co.,LimitedHTP2024-01-22
06974954641166 Acetabular bone raspXinhua Healthcare Industry Co.,LimitedHTP2024-01-22
06974954641173 Acetabular bone raspXinhua Healthcare Industry Co.,LimitedHTP2024-01-22
06974954641180 Acetabular bone raspXinhua Healthcare Industry Co.,LimitedHTP2024-01-22
06974954641197 Acetabular bone raspXinhua Healthcare Industry Co.,LimitedHTP2024-01-22