FDA.reportPublic FDA data

NA

Primary DI
10888551037532
Brand
NA
Company
STERILMED, INC.
Model
STR2296-33-410
Catalog number
2296-33-410
Device description
SAW BLADE MICRO OSCILLATING & SAGITTAL
Published
2018-06-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888551037532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088855103753210888551037532

GMDN Terms#

Term, Definition table
TermDefinition
Oscillating surgical saw blade, reprocessedA sterile, flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery. This device is designed with cutting teeth arranged in an arc or on a flat plane at its distal end; the teeth are at a 90° angle to its shaft. It cuts when it is moved in a rapid oscillating motion. This device enables side-cutting action to be performed within a restricted-access area. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(888)541-0078customerservice@sterilmed.com
+1(888)541-0078sterilmedcs@its.jnj.com

Regulatory Flags#

DUNS number
175899459
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
true
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
10888551045698Reprocessed DECANAV EP Catheter, D CurveRR7D282CTRR7D282CT2024-11-15
10888551045704Reprocessed DECANAV EP Catheter, F CurveRR7F282CTRR7F282CT2024-11-15
10888551045179NARD128208RD1282082021-10-12
10888551045186NARD128210RD1282102021-10-12
10888551045193NARD128207RD1282072021-10-12
10888551045209NARD128211RD1282112021-10-12
10888551010313NADYO411641162019-08-13
10888551021531NAINS305630562019-08-13
10888551000048NALIN997199712019-08-13
10888551012928NAAUT173051AUT1730512020-10-09
10888551012935NAAUT174001AUT1740012020-10-09
10888551012959NAAUT174311AUT1743112020-10-09
10888551013000NAAUT176613AUT1766132020-10-09
10888551013031NAAUT176647AUT1766472020-10-09
10888551022934NASYN310.86SYN310.862020-10-09
10888551022941NASYN310.870SYN310.8702020-10-09
10888551022958NASYN310.880SYN310.8802020-10-09
10888551022965NASYN310.890SYN310.8902020-10-09
10888551022972NASYN310.971SYN310.9712020-10-09
10888551022989NASYN310.972SYN310.9722020-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867614956Arthrex®ARTHREX, INC.GFA2026-05-25
08404535025156LARGE BONE BLADESPeter Brasseler Holdings, LLCGFA2026-03-23
B504OM4515700130DePuy MitekProvisionGFA2026-03-19
B504OM50715940Conmed LinvatecProvisionGFA2026-03-19
B504OMDC119090180Conmed LinvatecProvisionGFA2026-03-19
00810111225366Saw BladeTreace Medical Concepts, Inc.GFA2026-01-26
00810111225342Saw BladeTreace Medical Concepts, Inc.GFA2026-01-07
00810111225335Saw BladeTreace Medical Concepts, Inc.GFA2025-12-18
08681506801180SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIGFA2025-12-12
B39062901120331Reprocessed 3mm Straight Shaver BladeSURETEK MEDICALGFA2025-12-09
B3906290112040121Reprocessed 4mm Angled 12 Degree Shaver BladeSURETEK MEDICALGFA2025-12-09
B3906290112040601Reprocessed 4mm Angled 60 Degree Shaver BladeSURETEK MEDICALGFA2025-12-09
16974940305963endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940305970endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940305987endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940305994endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306007endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306014endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306021endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306038endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
06974940306048endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
06974940306055endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306069endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306076endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306083endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306090endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306106endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306113endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306120endophixSuzhou Endophix Co., Ltd.GFA2025-12-05
16974940306137endophixSuzhou Endophix Co., Ltd.GFA2025-12-05