FDA.report

DELTA XTEND

Primary DI
10603295115779
Brand
DELTA XTEND
Company
DEPUY (IRELAND)
Model
2307-30-009
Catalog number
230730009
Device description
DELTA Xtend HUMERAL SPACER TRIAL +9MM
Published
2018-06-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HWTTEMPLATE

Product Code Classifications

CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10603295115779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1060329511577910603295115779

GMDN Terms

TermDefinition
Humeral stem prosthesis trialA copy of a final humeral stem prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags

DUNS number
989365556
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10603295085980GLOBAL UNITE2100-70-2502100702502018-06-15
10603295088196GLOBAL ADVANTAGE2128-02-0502128020502018-09-24
10603295130192ATTUNE2544-01-0032544010032018-09-24
10603295130208ATTUNE2544-01-0042544010042018-09-24
10603295130222ATTUNE2544-01-0062544010062018-09-24
10603295395423ATTUNE2544-01-0092544010092018-09-24
10603295431275DEPUY REACH9505-05-1349505051342018-09-24
10603295431596DEPUY REACH9505-05-1359505051352018-09-24
10603295440222ATTUNE2546-00-4242546004242016-12-05
10603295443780ATTUNE2544-91-0012544910012020-06-11
10603295443797ATTUNE2544-91-0022544910022020-06-11
10603295443803ATTUNE2544-91-0032544910032020-06-11
10603295443810ATTUNE2544-91-0042544910042020-06-11
10603295451297ATTUNE2546-00-4162546004162016-12-05
10603295493549ATTUNE2544-11-0032544110032017-04-10
10603295496229ATTUNE2546-00-5162546005162018-01-24
10603295543879RECLAIM74-1000-1157410001152026-01-23
10603295543916RECLAIM74-1000-1207410001202026-01-23
10603295503309ATTUNE1506-61-3101506613102026-01-13
10603295503316ATTUNE1506-61-3201506613202026-01-13

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