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SampLok® Adapter Cap 3 Insert

FDA UDIEUDAMED

Class II (US FDA UDI)

by Itl Asia Pacific Sdn. Bhd.

Identity

Trade Name
SampLok® Adapter Cap 3 Insert FDA UDI
Generic Name
Blood collection tube holder, single-use FDA UDI
Device Name
SampLok® Adaptor Cap 3 (SAC 3) Insert is an optional accessory to be used with SAC 3 to facilitate collection of blood sample into vacuum tube(s). It is a single use device. FDA UDI
Model / Reference
A100763 FDA UDI
Description
SampLok® Adaptor Cap 3 (SAC 3) Insert is an optional accessory to be used with SAC 3 to facilitate collection of blood sample into vacuum tube(s). It is a single use device. FDA UDI

Identifiers

Catalog Number
A100763 FDA UDI
Primary DI / UDI-DI
09555240401557 FDA UDI
510(k) Number
K000777 FDA UDI
FDA Product Code
JKA FDA UDI
GMDN Term
Blood collection tube holder, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1675 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

SampLok® Adapter Cap 3 Insert by Itl Asia Pacific Sdn. Bhd. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Itl Asia Pacific Sdn. Bhd.

Sources (2)

  • FDA UDI 596fd7a5-cc8a-4330-878d-46f3b1c0a07b 38 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026