Aspen Surgical Puerto Rico Corp.

FDA Device Registration & Listing · Colinas de San Agustin, PR, US · Registration 2649798

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2649798
FEI Number
2649798
Entity Name
Aspen Surgical Puerto Rico Corp.
City/State/Country
Colinas de San Agustin, PR, US
Establishment Address
RD. 183, KM. 20.3, Colinas de San Agustin, PR 00771, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Aspen Surgical Products (Owner Number: 10061390)
Owner / Operator Contact Address
6945 Southbelt Drive S.E., Caledonia, MI 49316, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Mini-Scalpel Bard-Parker Bard-Parker Bard-Parker [Aspen]

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GDX Scalpel, One-Piece General, Plastic Surgery Class 1 878.4800 2019-10-14
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2019-10-14
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2019-10-14

Official Correspondent

Christopher Smith

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Aspen Surgical Products
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3021074643 Aspen Surgical Products, Inc. Douglas, AZ, US
8030607 Industrias Apson S.A de C.V AGUA PRIETA Sonora, MX
3001644167 Symmetry Surgical GmbH TUTTLINGEN Baden-Wurttemberg, DE
1836161 ASPEN SURGICAL PRODUCTS, INC. Caledonia, MI, US

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0039-2018 Teleflex Medical 1
Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0012-2008 Becton Dickinson & Company 1
Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008 Becton Dickinson & Company 1
Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

Similar Registrations

Registration Number Establishment Name Location
1052728 INVOTEC INTERNATIONAL, INC. Jacksonville, FL, US
1836161 ASPEN SURGICAL PRODUCTS, INC. Caledonia, MI, US
3005675811 QSUM BIOPSY DISPOSABLES LLC Pequot Lakes, MN, US
9611283 DIMEDA INSTRUMENTE GMBH TUTTLINGEN Baden-Wurttemberg, DE
3004050971 VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO., LTD. Dong Guan City Guangdong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2649798. Last updated year: 2026. Please use registration number 2649798 when referencing this establishment in official correspondence.
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