FDA.reportPublic FDA data

Deltec

Primary DI
30610586028469
Brand
Deltec
Company
SMITHS MEDICAL MD, INC.
Model
21-2027-24
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LGTSTIMULATOR, SPINAL-CORD, IMPLANTED FOR MOTOR DISORDERS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGTSTIMULATOR, SPINAL-CORD, IMPLANTED FOR MOTOR DISORDERS

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K830730000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K830730000PORT-A-CATH IMPLANTABLE CATH. SYSPharmacia, Inc.1983-06-30LJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30610586028469PackageGS112In Commercial Distribution
00610586028468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3061058602846930610586028469
00610586028468006105860284686105860284680610586028468

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous injection/infusion port needleA sterile, sharp bevel-edged, hollow tubular metal instrument attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106712748
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
false
Expiration date on label
true
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
30610586043325Level 1SWU-20012016-10-11
30610586043332Level 1SWU-20022016-10-11
30610586043349Level 1SWU-20032016-10-11
30610586043356Level 1SWU-20042016-10-11
30610586043363Level 1SWU-20072016-10-11
30610586043387Level 1SWU-20092016-10-11
30610586043394Level 1SWU-20102016-10-11
30610586043400Level 1SWU-20112016-10-11
30610586043417Level 1SWU-20132016-10-11
30610586043424Level 1SWU-2014L2016-10-11
30610586043431Level 1SWU-2014R2016-10-11
30610586043448Level 1SWU-20162016-10-11
30610586043455Level 1SWU-20182016-10-11
30610586043479Level 1SWU-21132016-10-11
30695085002769Level 1SW-2014L2016-10-11
30695085002776Level 1SW-2014R2016-10-11
30351688428350Portex0082012021-02-23
30610586016534Deltec21-2905-012015-09-01
30610586025635Deltec21-2770-242017-01-24
30610586025659Deltec21-2861-242016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00610586024088DeltecICU MEDICAL, INC.LGT2015-09-01
00610586028468DeltecICU MEDICAL, INC.LGT2015-09-01
30610586024089DeltecSMITHS MEDICAL MD, INC.LGT2015-09-01