FDA.reportPublic FDA data

PILLING

Primary DI
14026704655424
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN022646
Catalog number
P37335
Device description
CASE OSTEOTOME HOLDS CVD&STR 9"X11.5"X3"
Published
2020-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFIOSTEOTOME, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14026704655424Direct MarkingGS10
34026704655428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1402670465542414026704655424
3402670465542834026704655428

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle40degree
Depth180Millimeter
Width3Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

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Primary DI, Brand, Company table
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G149TBSB7870TBS BASICSACME ENTERPRISE.GFI2026-05-22
G149TBSB7880TBS BASICSACME ENTERPRISE.GFI2026-05-22
10889981443764SpecialsSeaspine Orthopedics CorporationGFI2026-03-03
D9281051992HF0SINUS INSTRUMENT #2 HF D/EW.H. Holden, Inc.GFI2026-02-19
10889981441340SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
10889981441357SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
10889981441364SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
10889981441371SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
03662663220873Breckenridge ACDF SystemHighridge Medical, LLCGFI2026-01-13
03662663220880Breckenridge ACDF SystemHighridge Medical, LLCGFI2026-01-13
03662663220897Breckenridge ACDF SystemHighridge Medical, LLCGFI2026-01-13
10889981440787SpecialsSeaspine Orthopedics CorporationGFI2026-01-07
03662663156783SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156790SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156806SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156813SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156820SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156837SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
00757770703708Bausch + LombBausch & Lomb IncorporatedGFI2025-12-12
00757770703715Bausch + LombBausch & Lomb IncorporatedGFI2025-12-12
00757770447046Bausch + LombBausch & Lomb IncorporatedGFI2025-12-11
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00810207783329Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783336Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783343Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783350Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783367Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783374Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24
00810207783381Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24