PyroCarbon PIP Total Joint System

Primary DI
00885556858400
Brand
PyroCarbon PIP Total Joint System
Company
Smith & Nephew, Inc.
Model
PIP-200-10P-WW
Catalog number
PIP-200-10P-WW
Device description
PIP SZ. 10 PROXIMAL
Published
2023-02-10
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
OMXHigh demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMXHigh Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger ProsthesisUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H010005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H010005000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556858400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556858400008855568584008855568584000885556858400

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, alligator, reusableA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24
00885556859742Titan Modular Shoulder SystemCSA-0920-20CSA-0920-202026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556858394PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858417PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858424PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858431PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858448PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858455PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858462PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
10381780000464Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000471Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000488Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000495Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000501Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000518Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000525Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000532Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20010PWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20020PWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20030PWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20040PWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20010DWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20020DWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20030DWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20040DWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18