FDA.report

NA

Primary DI
10888551009935
Brand
NA
Company
STERILMED, INC.
Model
DEP8241-62-000
Catalog number
8241-62-000
Device description
TAP CANNULATED CANCELLOUS S-COUPLE
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

Related Records

Contact Domains

Product Codes

CodeName
HWXTAP, BONE

Product Code Classifications

CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10888551009935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088855100993510888551009935

GMDN Terms

TermDefinition
Bone tap, reprocessedA sterile, metal, surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end, and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached, whereby it will typically be manually rotated. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods

Method
Ethylene Oxide

Contacts

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

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10888551022934NASYN310.86SYN310.862020-10-09
10888551022941NASYN310.870SYN310.8702020-10-09
10888551022958NASYN310.880SYN310.8802020-10-09
10888551022965NASYN310.890SYN310.8902020-10-09
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