FDA.reportPublic FDA data

ACUFEX

Primary DI
00885554037753
Brand
ACUFEX
Company
Smith & Nephew, Inc.
Model
72204046
Catalog number
72204046
Device description
ACUFEX TRUNAV RETROGRADE DRILL 10 MM
Published
2017-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFGBIT, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFGBit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885554037753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885554037753008855540377538855540377530885554037753

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, single-use, sterileA sterile metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010479235ECHELON71342011713420112015-09-28
03596010479266ECHELON71342014713420142015-09-28
03596010479273ECHELON71342015713420152015-09-28
03596010479297ECHELON71342017713420172015-09-28
03596010479303ECHELON71342018713420182015-09-28
03596010479310ECHELON71342019713420192015-09-28
03596010479341ECHELON71343012713430122015-09-28
03596010459749SYNERGY71309109713091092015-08-30
03596010459756SYNERGY71309110713091102015-08-30
03596010459787SYNERGY71309113713091132015-08-30
03596010459794SYNERGY71309114713091142015-08-30
03596010459817SYNERGY71309116713091162015-08-30
03596010459831SYNERGY71309118713091182015-08-30
03596010479259ECHELON71342013713420132015-09-28
03596010479280ECHELON71342016713420162015-09-28
03596010479358ECHELON71343013713430132015-09-28
03596010479365ECHELON71343014713430142015-09-28
03596010479389ECHELON71343016713430162015-09-28
03596010479396ECHELON71343017713430172015-09-28
03596010479402ECHELON71343018713430182015-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277326200MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277348813MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354005MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354012MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354029MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354074MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354296MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277355057MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277378261MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277378278MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277387805MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277390676MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10080196393152MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277322295MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277329485MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277330054MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277334663MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277336971MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277337121MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277337183MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277353480MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277354180MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277354647MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277355132MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277355439MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277356023MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277356702MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277372269MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277374478MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277377196MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29