FDA.reportPublic FDA data

Smoltap

Primary DI
10860008770612
Brand
Smoltap
Company
Smoltap, Inc.
Model
STSTR1
Catalog number
STSTR1
Device description
Infant Stabilizer Straps
Published
2022-10-27
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PRNPediatric Position Holder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PRNPediatric Position HolderGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860008770612PackageGS110In Commercial Distribution
00860008770615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000877061210860008770612
00860008770615008600087706158600087706150860008770615

GMDN Terms#

Term, Definition table
TermDefinition
Infant limb immobilizer, reusableA non-rigid device, usually made of a fabric and/or plastic materials, used to temporarily render parts of an infant's body immovable, e.g., the arms and/or feet while the patient undergoes therapeutic or diagnostic interventions. It will typically be used to prevent the patient from interrupting an intravenous (IV) infusion, pulling out a catheter, or interfering with wound care. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4017870819bob@smoltap.com

Regulatory Flags#

DUNS number
130517966
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
true
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
00860008770615SmoltapSTSTR1STSTR12022-10-27
00860008770608SmoltapSTCR1STCR12022-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20888277668000MEDLINEMEDLINE INDUSTRIES, INC.PRN2025-02-13
10888277668003MEDLINEMEDLINE INDUSTRIES, INC.PRN2025-02-13
04260764840557MedibinoNEO ring – TG PUR Gel - Size L - PU 6Kluba Medical GmbHPRN2024-09-06
04260764840571MedibinoNEO ring – TG PUR Gel - Size S - PU6Kluba Medical GmbHPRN2024-09-06
04260764840649MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size L - PU50Kluba Medical GmbHPRN2024-09-06
04260764840656MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size M - PU50Kluba Medical GmbHPRN2024-09-06
04260764840663MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size S - PU50Kluba Medical GmbHPRN2024-09-06
04260764840670MedibinoNEO disposable cover cotton knit WITH soft granules - Size L - PU 50Kluba Medical GmbHPRN2024-09-06
04260764840687MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU50Kluba Medical GmbHPRN2024-09-06
04260764840694MedibinoNEO disposable cover cotton knit WITH soft granules - Size S - PU50Kluba Medical GmbHPRN2024-09-06
04260764840564MedibinoNEO ring – TG PUR Gel - Size M - PU6Kluba Medical GmbHPRN2024-09-06
04260764840823MedibinoNEO disposable cover cotton knit WITH soft granules - Size L - PU 50Kluba Medical GmbHPRN2024-09-06
04260764840830MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU50Kluba Medical GmbHPRN2024-09-06
10810087355965CoulmedCoulmed Products Group LLCPRN2023-02-07
10810087350861CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351110CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351165CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351196CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351240CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351349CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351356CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351363CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351370CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351677CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351684CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351691CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351707CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351714CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351721CoulmedCoulmed Products Group LLCPRN2023-01-06
10810087351899CoulmedCoulmed Products Group LLCPRN2023-01-06