DEVICE: SL-PLUS (07611996081107)
Device Identifier (DI) Information
SL-PLUS
75004491
In Commercial Distribution
75004491
Smith & Nephew, Inc.
75004491
In Commercial Distribution
75004491
Smith & Nephew, Inc.
SL-PLUS MIA DETACHABLE RASP 9
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Bone file/rasp, manual | A 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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
aad6395b-85cd-42ce-b1a1-c2f0ba56562b
December 07, 2018
3
November 25, 2015
December 07, 2018
3
November 25, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)238-7538
GUDID@SMITH-NEPHEW.COM
GUDID@SMITH-NEPHEW.COM