Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006677911

FEI Number

3006677911

Entity Name

Crestpoint Management Ltd.

City/State/Country

Crestwood, MO, US

Establishment Address

9100 Watson Road Suite 100, Crestwood, MO 63126, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Crestpoint Management Ltd. (Owner Number: 10024298)

Owner / Operator Contact Address

9100 Watson Road, Saint Louis, MO 63126, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CRESTPOINT CRESTPOINT CRESTPOINT CRESTPOINT CRESTPOINT CRESTPOINT CRESTPOINT CRESTPOINT CRESTPOINT CRESTPOINT CRESTPOINT CRESTPOINT CRESTPOINT CRESTPOINT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-03-16
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-03-16
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-03-16
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2023-03-16
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2023-03-16
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-03-16
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2023-03-16
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2023-03-16
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-03-16
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-03-16
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-03-16
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-03-16
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-03-16
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-03-16

Official Correspondent

JAMES GRAMLICH

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Crestpoint Management Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

Similar Registrations

Registration Number	Establishment Name	Location
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3003365815	Bausch+Lomb Netherlands B.V. Amsterdam Logistics Centre	SCHIPOL RIJK Noord-Holland, NL
9616972	TITAN SURGICAL	KAZAN Tatarstan, RU
3006541044	Asuzna	Sialkot Punjab, PK
3007648354	FETZER MEDICAL GMBH & CO.KG	Tuttlingen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006677911. Last updated year: 2026. Please use registration number 3006677911 when referencing this establishment in official correspondence.