FDA.reportPublic FDA data

MEDLINE

Primary DI
20888277326207
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
231806400R
Catalog number
231806400R
Device description
00-2318-064-00 DRL BIT,STRGT SHANK 6.4
Published
2025-02-21
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
GFGBIT, SURGICAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277326207PackageGS16In Commercial Distribution
10888277326200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827732620720888277326207
1088827732620010888277326200

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-useA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

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