FDA.report

NA

Primary DI
10888551004572
Brand
NA
Company
STERILMED, INC.
Model
ACU010650
Catalog number
10650
Device description
KNIFE STRAIGHT SHARP TIP DISPOSABLE
Published
2018-06-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HTSKNIFE, ORTHOPEDIC

Product Code Classifications

CodeDeviceSpecialtyClass
HTSKnife, OrthopedicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10888551004572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088855100457210888551004572

GMDN Terms

TermDefinition
Reciprocating surgical saw blade, single-useA sterile, flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a dedicated sternum saw blade). This device is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is powered in a rapid reciprocating movement (a back and forth motion like a jigsaw) against the object to be cut. The end of the blade is typically not protected. This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(888)541-0078customerservice@sterilmed.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 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 DIBrandCompanyProduct codePublished
00192896122796McIlwraith Bistouri KnifeSONTEC INSTRUMENTS, INC.HTS2026-03-10
00853508002645BE-ST Sheathed Bayonet Surgical Knife Lacey Manufacturing Company, LLCHTS2026-03-02
00853508002539BE-ST Sheathed Bayonet Surgical Knife Lacey Manufacturing Company, LLCHTS2026-02-16
00840967154527SigmaALPHATEC SPINE, INC.HTS2025-07-23
00192896121560Arthroscopic Bayonet KnifeSONTEC INSTRUMENTS, INC.HTS2025-05-14
10888277392687MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-04-17
00853508002621BESTLacey Manufacturing Company, LLCHTS2025-03-25
10080196392582MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-22
10080196392636MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10080196392643MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10080196392667MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392564MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392571MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392588MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392595MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392601MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392618MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392625MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392632MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392649MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392656MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392663MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392670MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392694MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392700MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392717MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10888277392724MEDLINEMEDLINE INDUSTRIES, INC.HTS2025-02-21
10080196392575MEDLINE RENEWALMEDLINE INDUSTRIES, INC.HTS2025-02-11
00843575121219b-ONE Hip SpecialtyB-ONE ORTHO, CORP.HTS2025-01-22
08800147701097Target Endoscopic InstrumentSOLENDOS Inc.HTS2024-12-09